Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election Restrictions
1. Applicant's election with traverse of Group II and species (SARS-CoV-2) in the reply filed on 2/2/2026 is acknowledged.
The traversal is on the ground(s) that: the strip has been optimized and improved under the combined use of the CRISPR system and the RAA amplification; Li et al. and Huang et al. utilize commercially purchased products; the sensitivity of the present application is the highest; the combination produces synergistic technical effects; Huang et al.’s method can only achieve 1x10-17 M and Li et al.’s method can detect up to 1x10-14M; the sensitivity of the test strip has been enhanced; the methods in Li et al. and Huang et al. focus more on the CRISPR system itself, and the test strips are directly purchased; the method of the present application emphasizes optimization of the test strip to match CRISPR and RAA, which cannot be achieved by the prior art; the present application ensures the sensitivity of CRISPR nucleic acid detection while avoiding false positive results caused by subjective interpretation errors, enhancing accuracy; the two groups share the same special technical features, Groups I and II comply with unity. .
This is not found persuasive because: even in view of applicant’s amendments, the common technical feature is that indicated and recited in claim 1 and amended claim 13; further, it is noted applicant has not appeared to directly address the claim language and common technical feature in view of Huang et al. and Li et al., rather features of the application; applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references; therefore, no special technical feature exists for Groups I-II as defined by PCT Rule 13.2 because it does not define a contribution over the prior art; because the technical feature of Groups I-II is not a special technical feature, unity of invention is lacking.
The requirement is still deemed proper and is therefore made FINAL.
It is further noted applicant has not made election of species as required on p. 6 of the Restriction Action issued 12/3/2025.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/2/2026.
Claims 13, 15, 17-25 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Since a certified English translation of has not been provided for CHINA 202010533739.4, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 6/10/2021.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 12/12/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
4. The abstract of the disclosure is objected to because: the abstract is too long. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
5. Claims 13, 15, 17-25 are objected to because of the following informalities:
As to claims 15, 17-25, for improved language, the claims should recite “wherein” as opposed to “characterized in that”.
As to claim 13, the term RAA should be spelled out in its entirety before abbreviation on first recitation. Further, for improved grammar, the claim should recite steps such as “amplifying,” “adding,” “detecting”. Further the claim should recite “an absorbent pad”. Further, “NC membrane” should be spelled out in its entirety before abbreviation on first recitation.
Further as to claim 15, for improved language and antecedent basis, the claim should recite “pathogenic nucleic acid”.
Further as to claim 25, there is a space between “SARS-Co” and “V-2”, which should be deleted.
Appropriate correction is required.
6. Applicant is advised that should claim 15 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 13, 15, 17-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
See claims 13, 15, 17-25 as submitted 2/2/2026.
The instant claims are drawn to a method of detecting whether a target nucleic acid or a sample to be tested is a pathogenic nucleic acid, comprising detection and judging positive or negative results, which is a statutory category of invention (Step 1: YES).
The instant claims are directed to a method of detecting whether a target nucleic acid or a sample to be tested is a pathogenic nucleic acid, comprising detection and judging positive or negative results. As such, the instant claims recite judicial exceptions (JE) in the form of mental processes or an abstract idea (Step 2A, Prong One: YES).
The crux of the claimed method is the judgment of positive or negative results after detection of CRISPR reaction product. The claims do not recite e.g., any particular treatment or prophylaxis; rather the instant claims merely recite insignificant extra-solution activities. As such, the instant claims do not recite additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
Further, the claims do not recite additional elements that amount to significantly more than the judicial exception. As indicated below, the detection steps as recited in claims 13, 15, 17-25 are known to one of ordinary skill in the art. It was well-understood, routine, and conventional (WURC) at the time of filing to use amplification steps and products with CRISPR reaction systems for methods of detection (See Huang et al., Subsoontorn et al., Li et al. and supporting references as indicated below). As such, beyond the JE, the instant claims only recite WURC data-gathering steps. These WURC data-gathering steps constitute insignificant extra-solution activities. As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C § 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 13, 15, 17, 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN110184329A)(cited in applicant's IDS submitted 12/12/2022)(See
also the WIPO translation of CN110184329A; previously cited) in view of Subsoontorn et al. (“The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis,” Scientific Reports 10:22349 (2020))(See PTO-892: Notice of References Cited) and Li et al. (CN111235313A)(cited in applicant's IDS submitted 12/12/2022)(See also the WIPO translation of CN111235313A; previously cited).
See claims 13, 15, 17, 19-23 as submitted 2/2/2026.
Huang et al. teaches: detection method based on CRISPR/Cas12a (known as Class II, Type V) and isothermal amplification RPA [0002](as recited in claims 13, 17, 19); comprising target nucleic acid-specific crRNA and reporter DNA molecule, and lateral flow immunochromatography test strip detection wherein a sample loading area, a Gold NP anti-FITC antibody area, streptavidin band (control band) and antibody band (detection band) are provided on the test strip [0012, 0026](as recited in claims 13, 23); lateral flow test strip [0026](as recited in claim 13), interpreted to read upon “NC membrane” or nitrocellulose as known in the art (See Wang et al. (“Electrospun nitrocellulose membrane for immunochromatographic test strip with high sensitivity,” Mikrochim Acta. Nov. 6: 187 (12):644 (abstract)(2020))(See PTO-892: Notice of References Cited).
Huang et al. does not teach: RAA for obtaining RT-RAA amplification product; streptavidin is T line; secondary antibody of colloidal gold labeled antibody is a C line, reporter molecule is RNA type.
Subsoontorn et al. teaches: isothermal amplification (abstract); wherein RT-RPA or RT-RAA are known methods for isothermal amplification (p. 2)(as recited in claims 13, 19, 20).
Li et al. teaches: detection line method wherein blue is displayed for positive control, red
and blue displayed for negative control [0020]; wherein positive control should only show blue test line (interpreted as no T line, C line), while negative control should show two test lines, red and blue (interpreted as T line, C line) [0020]; RNA reporter [0034]; in which both ends are labeled with FAM (group) and bio [0036]; rapid detection [0007]; SARS-CoV [0064](as recited in claim 15, 21, 22)
One of ordinary skill in the art would have been motivated to use amplification method as taught by Subsoontorn et al. as amplification method as taught by Huang et al. Huang et al. teaches amplification methods such as RPA, and Subsoontorn et al., which also teaches amplification methods such as RT-RPA, also teaches RT-RAA as another alternative amplification method (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, one of ordinary skill in the art would have been motivated to use detection line method and RNA reporter group of Li et al. in method as used by Huang et al. and Subsoontorn et al. Huang et al. and Subsoontorn et al. teaches use of CRISPR/Cas with reporter molecule, and Li et al. teaches such a reporter molecule (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, Li et al. teaches the advantage of using detection line method with test strip for easier detection.
One of ordinary skill in the art would have had a reasonable expectation of success for
using methods and components of Subsoontorn et al. and Li et al. with the method of Huang et al. There would have been a reasonable expectation of success given the underlying materials and methods (nucleic acid detection as taught by Huang et al., Subsoontorn et al. and Li et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
9. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. in view of Subsoontorn et al. and Li et al. as applied to claims 13, 15, 17, 19-23 above, and further in view of Harrington et al. (WO2020142739A1)(See PTO-892: Notice of References Cited).
See claim 18 as submitted 2/2/2026.
See the teachings of Huang et al. in view of Subsoontorn et al. and Li et al. above.
Huang et al. in view of Subsoontorn et al. and Li et al. does not teach: characterized in that: the reporter RNA consists of 20 U, and both ends of the reporter RNA are labeled with biotin and fluorescein respectively.
Harrington et al. teaches: nucleic acid detection [0004]; wherein detector nucleic acid is used interchangeably with reporter or reporter molecule [0208]; including use of detector nucleic acids [0098]; including wherein detector nucleic acid can be 20 nucleotides in length; at least one uracil ribonucleotide; at least two uracil [0098]; detection moiety can comprise fluorescent dye, biotin [0103. 0212]; Fluorescein (Table 4).
One of ordinary skill in the art would have been motivated to use reporter as taught by Harrington et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. Huang et al. in view of Subsoontorn et al. and Li et al. teaches use of a reporter molecule in detection methods, and Harrington et al. teaches such a reporter (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further the reporter embodiment as recited in claim 18 is considered to be an obvious embodiment in view of the teachings or suggestions of Harrington et al., absent unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for
using reporter as taught by Harrington et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection methods as taught by Harrington et al. and Huang et al. in view of Subsoontorn et al. and Li et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. in view of Subsoontorn et al. and Li et al. as applied to claims 13, 15, 17, 19-23 above, and further in view of Zhang et al. (US20200254443A1)(See PTO-892: Notice of References Cited).
See claim 24 as submitted 2/2/2026.
See the teachings of Huang et al. in view of Subsoontorn et al. and Li et al. above. It is noted that Huang et al. teaches NTP, T7 [0048]; RNAse inhibitor [0052]; Li et al. also teaches LwCas13a [0034]; MgCl [0011].
Huang et al. in view of Subsoontorn et al. and Li et al. does not teach: HEPES; MgCl2.
Zhang et al. teaches: CRISPR based diagnostics (title); buffer optimization including using MgCl2 and HEPES to boost signal [0106].
One of ordinary skill in the art would have been motivated to use components as taught by Zhang et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. Huang et al. in view of Subsoontorn et al. and Li et al. teaches methods and reagents comprising CRISPR/Cas for use in detecting nucleic acids, and Zhang et al., which also teaches CRISPR/Cas diagnostics, teaches reagents known and used in the art for such methods, including advantages including buffer optimization. Further, concentrations as recited in claim 24 are considered to be those determined by routine optimization to one of ordinary skill in the art in view of Huang et al. in view of Subsoontorn et al. and Li et al. and further in view of Zhang et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for using components as taught by Zhang et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection methods as taught by Zhang et al. and Huang et al. in view of Subsoontorn et al. and Li et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
11. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. in view of Subsoontorn et al. and Li et al. as applied to claims 13, 15, 17, 19-23 above, and further in view of Kou et al. (CN111270012)(See PTO-892: Notice of References Cited)(See also the WIPO English translation of CN111270012)(See PTO-892: Notice of References Cited)
See claim 25 as submitted 2/2/2026.
See the teachings of Huang et al. in view of Subsoontorn et al. and Li et al. above.
Huang et al. in view of Subsoontorn et al. and Li et al. does not teach: characterized in that if the target nucleic acid to be detected is a SARS-Co V-2 genome, the nucleotide sequence of the corresponding crRNA is SEQ ID NO: 2, and the primers in the RT-RAA amplification kit for amplifying the target nucleic acid are a primer shown in SEQ ID NO: 3 or SEQ ID NO: 11 and a primer shown in SEQ ID NO: 4 or SFQ ID NO: 12;
Kou et al. teaches: detection of coronavirus [0002]; RT-RAA [0018]; including crRNA COVID-19 N gene targeted crRNA forward PCR primer WCOVnp-crRNA123-F, which has 100% identity with instant SEQ ID NO: 2 (See Result 1 of STIC Sequence Search 20260507_164555_us-18-009-975-2.rng in Supplemental Content Tab); primer SEQ ID NO: 4, which has 100% identity with instant SEQ ID NO: 3 (See Result 1 of STIC Sequence Search 20260507_164555_us-18-009-975-3.rng in Supplemental Content Tab); primer SEQ ID NO: 5, which has 100% identity with instant SEQ ID NO: 4 (See Result 1 of STIC Sequence Search 20260507_164754_us-18-009-975-4.rng in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use components as taught by Kou et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. Huang et al. in view of Subsoontorn et al. and Li et al. teaches RT-RAA and components used for amplification and detection of SARS-CoV-2, and Kou et al., which also teaches RT-RAA and components used for amplification and detection of SARS-CoV-2, teaches such components (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using components as taught by Kou et al. with the method as taught by Huang et al. in view of Subsoontorn et al. and Li et al. There would have been a reasonable expectation of success given the underlying materials and methods (detection and amplification methods as taught by Kou et al. and Huang et al. in view of Subsoontorn et al. and Li et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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